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Clinical Trials in the USA / NCT03706833
Active, not recruiting Not applicable

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

NCT03706833 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2018-11-30
Last updated
2026-07-08

Condition(s) studied

Degenerative Mitral Valve DiseaseMitral RegurgitationMitral InsufficiencyFunctional Mitral Regurgitation

Investigational drug(s) / intervention(s)

Edwards PASCAL SystemAbbott Mitraclip System

Edwards PASCAL System: Transcatheter mitral valve repair with the Edwards PASCAL System

Abbott Mitraclip System: Transcatheter mitral valve repair with the Abbott Mitraclip System

Study summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Eighteen (18) years of age or older * Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements. * Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only). * Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only) * Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip * Mitral regurgitation (3+ to 4+) by echo * Suitable valve and regurgitant jet morphology * Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only) * LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only) Exclusion Criteria: * Patient in whom a TEE is contraindicated or screening TEE is unsuccessful * Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation * Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure) * Clinically significant, untreated coronary artery disease * Recent stroke * Other severe valve disorders requiring intervention * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months * Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair) * Severe tricuspid regurgitation or tricuspid valve disease requiring surgery * Active rheumatic heart disease or rheumatic etiology for MR * Severe aortic stenosis or regurgitation * Known history of untreated, severe carotid stenosis * Recent deep vein thrombosis (DVT) or pulmonary embolism (PE) * Severe COPD * Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment * Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Primary outcome measure(s)

Trial sites (81)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona
TMC Healthcare Tucson Arizona
Scripps Memorial Hospital La Jolla La Jolla California
Cedars Sinai Medical Center Los Angeles California
UC Irvine Orange California
Sutter Medical Center-Sacramento Sacramento California
Kaiser Permanente San Francisco San Francisco California
University of California, San Francisco San Francisco California
Stanford University Stanford California
Los Robles Hospital and Medical Center Thousand Oaks California
Medical Center of the Rockies Loveland Colorado
Medstar Washington Hospital Center Washington D.C. District of Columbia
The Cardiac and Vascular Institute Research Foundation Gainesville Florida
Mount Sinai Miami Beach Florida
NCH Rooney Heart Institute Naples Florida
AdventHealth Orlando Orlando Florida
Piedmont Healthcare Atlanta Georgia
Emory University Hospital and Emory University Hospital Midtown Atlanta Georgia
Northwestern University Chicago Illinois
St. Vincent Heart Center Carmel Indiana
University of Iowa Hospitals & Clinics Iowa City Iowa
Massachusetts General Hospital Boston Massachusetts
Brigham and Woman's Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
University of Michigan Ann Arbor Michigan
Henry Ford Hospital Detroit Michigan
Mayo Clinic Rochester Minnesota
St.Luke's Hospital of Kansas City Kansas City Missouri
Washington University/Barnes Jewish Hospital St Louis Missouri
Morristown Medical Center Morristown New Jersey
Rutgers-RWJMS New Brunswick New Jersey
Albany Medical College Albany New York
State University of New York at Buffalo Buffalo New York
NYU Langone Hospital - Long Island Mineola New York
NYU Langone Health New York New York
Columbia University Medical Center/New York Presbyterian Hospital New York New York
Lenox Hill Hospital and North Shore University New York New York
Rochester General Hospital Rochester New York
Montefiore Medical Center The Bronx New York
The Christ Hospital Cincinnati Ohio

+ 41 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03706833 on ClinicalTrials.gov ↗ ← All trials in the USA